Maestro Rechargeable System
FDA premarket approval P130019/S019 · decided 2019-02-15
Approval details
- PMA number
- P130019
- Supplement
- S019
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Maestro Rechargeable System
- Generic name
- neuromodulator for obesity
- Applicant
- Reshape Lifesciences, Inc.
- Date received
- 2018-12-17
- Decision date
- 2019-02-15
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- PIM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Roseville, MN
- Statement
- Approval of the revised protocol which includes modification to the follow-up schedule for the post-approval study (PAS) protocol.
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